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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02523755
Other study ID # EIT
Secondary ID
Status Completed
Phase Phase 4
First received July 28, 2015
Last updated December 5, 2016
Start date September 2015
Est. completion date December 2016

Study information

Verified date December 2016
Source Universitair Ziekenhuis Brussel
Contact n/a
Is FDA regulated No
Health authority Belgium: Federal Agency for Medicines and Health Products, FAMHP
Study type Interventional

Clinical Trial Summary

With an efficient epidural analgesia the physiological effects of pain are disabled during labor. Pain may cause an increase of minute volume, oxygen consumption and a decrease of paCO2 (Arterial CO2 pressure). The study will evaluate the lung function before and after labor with and without epidural analgesia. With more efficient breathing, the occurence of atelectasis should be reduced; this effect will be investigated in these settings for the first time with the electrical impedance tomography, which is a completely non-invasive measure.


Description:

The bedside efficacy of the electrical impedance tomography (EIT) in intensive care settings during mechanical ventilation is known. However, no studies demonstrate its utility during epidural analgesia for labor.

The purpose of this study is to evaluate lung function and atelectasis in pregnant women with or without epidural analgesia, during labor and after delivery.

Only adult consenting patients ASA I & ASA II (American Society of Anaesthesiologists) are included in the study. According to institutional protocols lumbal epidural catheter is inserted and tested at the start of the labor, while patients' parameters are monitored.

Refusal to epidural analgesia, technical difficulties to insert the epidural catheter or any medical contraindication will result in inclusion of these patients in the control group.

Measurement with EIT is not invasive and harmful neither for the mother nor for the child.

It consists of putting a belt around the chest; this belt is linked to a monitor which measures the impedance of the different lung regions.

Electrical impedance measurements will be done for short periods of maximum 5 min. each as follows:

1. Placement before injection of local anesthetics through the epidural catheter in the study goup; in the control subset placement of the belt will be done when an epidural anesthetic would have been considered.

2. 1 hour after placement of the belt

3. 1 hour after delivery

These periods will be compared.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date December 2016
Est. primary completion date November 2016
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- ASA I

- ASA II

Exclusion Criteria:

- Caesarian

- < 18 years

- Expulsions

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Drug:
Epidural analgesia Ropivacaine
Measurement of regional distribution as assessed by EIT before and after injection of local anesthetics
Absence of epidural analgesia
Measurement of regional distribution as assessed by EIT before and after delivery

Locations

Country Name City State
Belgium Universitair Ziekenhuis Brussel Jette Vlaams Brabant

Sponsors (1)

Lead Sponsor Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Better lung function after labor with epidural analgesia Using EIT we will map the degree of atelectasis 24h Yes
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